RecruitingNCT06763081

Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation

Pharmacogenomics of Selective Serotonin Reuptake Inhibitor (SSRI)-Induced Behavioural Activation in Children and Youth (PGx-SImBA)

Sponsor

University of Manitoba

Enrollment

160 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

Behavioral Activation Major Depressive Disorder Anxiety Disorders Antidepressant Drug Adverse Reaction Obsessive Compulsive Disorder (OCD)Major Depression

Summary

The purpose of this study is to identify and validate a panel of genetic markers associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioural activation in children and youth with major depressive disorder (MDD), anxiety disorders, or obsessive-compulsive disorder (OCD) that could be used clinically to reduce the incidence of this adverse event and improve health outcomes.

Eligibility

Min Age: 6 YearsMax Age: 24 Years

Inclusion Criteria6

Resident of Manitoba
Age, 6 - 24 years
Diagnosis of major depressive disorder (MDD), anxiety disorder, or obsessive-compulsive disorder (OCD)
Current or past history of selective serotonin reuptake inhibitor (SSRI), e.g., Citalopram \[Celexa\], Escitalopram \[Cipralex\], Fluoxetine \[Prozac\], Fluvoxamine \[Luvox\], Sertraline \[Zoloft\], Paroxetine \[Paxil/Plaxil CR\]) therapy
\[Cases Only\] Have experienced behavioural side effects after taking an SSRI that resolved after reducing the dose or discontinuation of the drug
\[Controls Only\] Did not experience any side effects after taking an SSRI for eight (8) continuous weeks

Exclusion Criteria5

Inability of parent/legal guardian/mature minors to give informed consent
Inability of the child (6 - 13 years) to give informed assent
Unwillingness of the child to provide a saliva sample for genetic analysis
Current, past, or suspected diagnosis of attention deficit hyperactivity disorder (combined or hyperactive type), oppositional defiant disorder, conduct disorder, bipolar disorder, psychotic disorder, pervasive developmental disorder
History of liver or bone marrow (hematopoietic cell) transplant.